JP6643452B2 - Headgear for patient interface - Google Patents

Description

  The present invention generally relates to a mask that covers a respiratory passage and a structure used to secure the mask to the head. More particularly, the invention relates generally to configurations that provide a predetermined on-board length and a longer length for wearing, and a non-extensible structure having at least one of an adjustment mechanism.

  Obstructive sleep apnea (OSA) is a sleep state in which the back of the throat becomes very relaxed during bedtime, narrowing the airway or even completely obstructing the airway. Restriction or obstruction of the airways can cause breathing to stop or become very shallow for a few seconds or longer.

  Continuous positive airway pressure (CPAP) is used to treat OSA. CPAP delivers a stream of pressurized air that opens the airway with its support. The pressurized airflow may be delivered to a user using the interface. The interface may include a mask and headgear, for example, an elastic or elastic strap.

  When wearing the interface, the elastic straps stretch to allow the headgear to slide over the user's head. When released, the elastic strap has a tendency to pull the interface toward the user's face.

As the pressure in the mask rises (e.g., to 12cm H ₂ O from 4 cm H ₂ O), the mask is going to move away from the user's face. This is because the strap for fixing the mask to the face is elastic. In some masks, the force exerted by the mask on the user's face is reduced when the elastic strap is stretched by the force moving the mask away from the user's face. Therefore, as the pressure increases, the masks can leak and, if suitably sealed at higher pressures (eg, 12 cm H ₂ O), the elasticity of the straps At lower treatment pressures (eg, 4 cm H ₂ O), unnecessary high pressure is applied to the user's face.

  It is an object of the present invention to provide an interface that provides the industry and users with at least useful options.

  Certain aspects of the invention relate to headgear for use with an interface, wherein the headgear is generally non-elastic or inelastic. It is believed by the inventors that totally non-elastic headgear is superior to elastic headgear, for example, when used with pressures that vary dramatically over a treatment session. However, generally non-elastic headgear can be difficult to install and use. For example, with totally non-elastic headgear, it is necessary to disconnect the headgear during wear, which can be problematic when it comes to adjusting the headgear for proper wearing. Detachment can also be difficult for some users to manage.

  Some features, aspects and advantages of the present invention relate to an interface assembly for use in providing respiratory therapy. The interface assembly may include a mask. The mask includes a frame and a seal supported by the frame. The headgear includes a mask and (i) an adjustment mechanism configured to be set to a working length of the loop defined by the mask and the headgear; and (ii) the mask and the headgear upon exceeding a predetermined force. The defined loop may be selectively lengthened and connected to at least one of the break-fit assemblies configured to return to the use length when the predetermined force is not exceeded.

  In some such configurations, the interface assembly has both an adjustment mechanism and a break-fit assembly. In some such configurations, the adjustment mechanism couples the headgear to the mask. In some such configurations, the adjustment mechanism is positioned on the mask. In some such configurations, the adjustment mechanism is positioned on the headgear.

  In some such configurations, the break-fit assembly joins the headgear and the mask. In some such configurations, the break-fit assembly joins the adjustment mechanism and the mask. In some such configurations, the break-fit assembly joins the adjustment mechanism and the headgear. In some such configurations, the break-fit assembly is positioned on the frame of the mask. In some such configurations, the break-fit assembly is positioned on the headgear.

  In some such configurations, the break-fit assembly includes a magnetic coupling.

  In some such configurations, the break-fit assembly includes a mechanical connection.

  In some such configurations, the adjustment mechanism is positioned on the mask. In some such configurations, the adjustment mechanism includes a squeeze to lock the mechanism. In some such configurations, the adjustment mechanism includes a squeeze to unlock the mechanism.

  In some such configurations, the break-fit assembly includes a biasing member. In some such configurations, the biasing member includes an elastic sleeve. In some such configurations, the biasing member includes a spring.

  In some such configurations, the headgear is substantially inextensible.

  Some features, aspects and advantages of the present invention relate to a mask and headgear system including a mask and headgear. The mask includes a frame and a seal supported by the frame. Headgear can be connected to the mask. The break-fit assembly may be configured to elongate when a force exceeding a preselected force is applied. The mask, headgear, and break-fit assembly together define a loop elongated by a force that exceeds a preselected force.

  In some such configurations, when a force exceeding a preselected force is applied, the resulting loop elongation allows the user to wear and position the mask on the user's head and face. Is sufficient to allow the user to remove the interface from the user's head and face. In some such configurations, the break-fit assembly resists elongation and remains connected in general use when less than a preselected force is applied.

  Some features, aspects and advantages of the present invention relate to a break-fit assembly for a mask and headgear assembly. The break-fit assembly includes a mechanical connection that resists elongation from a first length to a second length until a force exceeding a predetermined force is applied. The mechanical connection includes a plurality of portions and an extensible biasing member connecting two or more of the plurality of portions.

  In some such configurations, the extensible biasing member exhibits at least one of (1) elastic properties and (2) spring properties. In some such configurations, the extensible biasing member provides a connection between portions of the mechanical connection of the break-fit assembly. In some such configurations, the mechanical coupling requires a first force for disconnection and a second force for reconnection, where the second force is less than the first force. .

  Some features, aspects and advantages of the present invention relate to a break-fit assembly for a mask and headgear assembly. The break-fit assembly includes a magnetic coupling that resists elongation from a first length to a second length until a force exceeding a predetermined force is applied. The magnetic coupling includes a plurality of portions and an extension portion.

  In some such configurations, the magnetic coupling fulfills a biasing function for a break-fit assembly. In some such configurations, the extension provides a connection between two or more portions of the magnetic coupling.

  Some features, aspects and advantages of the present invention include a mask configured to be positioned on a user's face and an adjustment mechanism configured to adjust the size of headgear to fit different users. And a mask and headgear system.

  In some such configurations, the headgear includes a substantially non-elastic material. In some such configurations, the headgear is substantially inextensible. In some such configurations, the adjustment mechanism includes a buckle. In some such configurations, the buckle includes a hook-and-loop fastener. In some such configurations, the adjustment mechanism includes a reel and a coil spring. In some such configurations, the adjustment mechanism includes a hoisting mechanism, a spool connected to the hoisting mechanism, and a flexible material band configured to wind around the spool.

  As used herein and in the claims, the term "comprising" means "comprising at least a portion of". In interpreting statements containing "comprising" in the present specification and claims, there may be other features or features which are preceded by this term. Related terms such as "comprise" and "comprises" are interpreted similarly.

  In this specification, which refers to patent specifications, other external documents, or other sources, this is generally to provide context for describing features of the invention. Unless otherwise specified, reference to such external documents in any jurisdiction is based on the knowledge that such documents, or such sources are prior art, or common general knowledge in the art. It should not be deemed to be an approval to form a part.

  Various aspects of the interface will be described with reference to the accompanying drawings.

FIG. 4 is a front view of an interface arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 2 is a side view of the interface of FIG. 1. FIG. 9 is a perspective view of another interface arranged and configured in accordance with certain features, aspects, and advantages of the present invention. 4A-C are a series of diagrams illustrating the interface of FIG. 3 being worn by a user. FIG. 4 is a rear view of headgear arranged and configured in accordance with certain features, aspects and advantages of the present invention. FIG. 9 is a perspective view of another interface arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 7 is a top view of the interface of FIG. 6. 8A and 8B include two simplified top views of the interface of FIG. 6, showing how the strap length can be temporarily increased for wearing the interface. FIG. 4 is a top view and two cross-sectional views of an interface arranged and configured in accordance with certain features, aspects and advantages of the present invention. FIG. 3 is a top view, two cross-sectional views, and partial side views of an interface arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 4 is a top view of a break-fit assembly arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 12 is a front view of a portion of the break-fit assembly of FIG. 11 in an open state. FIG. 2 is a top cross-sectional view of a break-fit assembly arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 14 is an enlarged view of a portion of the break-fit assembly of FIG. FIG. 14 is a top cross-sectional view of the break-fit assembly of FIG. FIG. 2 is a top cross-sectional view of a break-fit assembly arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 17 is another top cross-sectional view of the break-fit assembly of FIG. FIG. 4 is a top view of an interface arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 19 is a partial view of a portion of the interface of FIG. 18 showing the adjustment mechanism. FIG. 19 is another partial view of a portion of the interface of FIG. 18. FIG. 4 is a top view of an interface having an adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 22 is a simplified view of a portion of the adjustment mechanism of FIG. 21. FIG. 22 is a simplified view of a portion of the adjustment mechanism similar to the view of FIG. 21, with the adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 3 is an illustration of an interface having an adjustment mechanism arranged and configured in accordance with certain features, aspects and advantages of the present invention. FIG. 25 is a partial view of a portion of the interface of FIG. 24. FIG. 26 is a cross-sectional view of a portion of the portion of FIG. 25. FIG. 25 is a partial view of a portion of the interface of FIG. 24. FIG. 25 is a partial view of a portion of the interface of FIG. 24. FIG. 29 is a cross-sectional view of a portion of the portion of FIG. 28. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 6 is a schematic view of another adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 2 is a perspective view of an interface with an adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 33 is a schematic diagram of the interface of FIG. 32. FIG. 33 is a view of a portion of the adjustment mechanism of FIG. 32. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 36 is another schematic diagram of the adjustment mechanism of FIG. 35. FIG. 36 is a further schematic view of the adjustment mechanism of FIG. 35. FIG. 36 is a side view of an interface using the adjustment mechanism of FIG. 35. FIG. 36 is a side view of another interface using the adjustment mechanism of FIG. 35. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 6 is a schematic view of another adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 43 is a schematic view of an interface having the adjustment mechanism of FIG. 42. FIG. 44 is another schematic diagram of the interface of FIG. 43. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 46 is another schematic diagram of the adjustment mechanism of FIG. 45. FIG. 46 is a schematic view of an interface of the adjustment mechanism of FIG. 45. FIG. 48 is another schematic diagram of the interface of FIG. 47. FIG. 46 is another schematic diagram of an interface having the adjustment mechanism of FIG. 45. FIG. 46 is a schematic diagram of another interface having the adjustment mechanism of FIG. 45. FIG. 2 is a schematic illustration of an adjustment mechanism arranged and configured in accordance with certain features, aspects, and advantages of the present invention. FIG. 52 is a schematic view of an interface having the adjustment mechanism of FIG. 51. FIG. 53 is a schematic diagram of a portion of the interface of FIG. 52. It is a perspective view of the strap which has an adjustment mechanism. FIG. 56 is a pair of cross-sectional views of the strap of FIG. 54. FIG. 55 is a pair of enlarged cross-sectional views of the strap of FIG. 54. FIG. 6 is a cross-sectional view of a group of other strap configurations arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 9 is a pair of perspective views of a further strap configuration having an adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 2 is a perspective view of an interface with an adjustment mechanism arranged and configured according to certain features, aspects and advantages of the present invention. FIG. 60 is a front view of the interface of FIG. 59. FIG. 60 is an enlarged perspective view of a portion of the interface of FIG. 59. FIG. 63 is a pair of cross sections of the interface portion of FIG. 61.

  1 and 2 show examples of the interface 100. FIG. The illustrated interface 100 includes a seal 102 supported on a frame 104. A conduit 106 is connected to at least one of the seal 102 and the frame 104. Conduit 106 can supply breathing gas to the user.

  Referring to FIGS. 1 and 2, a headgear 110 is connected to at least one of the seal 102 and the frame 104. In the example arrangement shown in FIGS. 1 and 2, headgear 110 includes a single strap extending around the user's head. The frame 104 can include two attachment points 112, and the strap 110 includes cooperating attachment members 114. In some configurations, seal 102 may include an attachment point 112. Any suitable attachment points 112 and attachment members 114 can be used. The cooperating points 112 and members 114 make connecting and disconnecting the mounting points 112 and the mounting members 114 simple and easy. In some configurations, in addition to securing headgear 110, at least one of attachment point 112 and / or attachment member 114 includes a suitable mechanism for adjusting the length of headgear 110.

  The illustrated headgear 110 may be a single strap 110 around the back of the head, as described above. To increase stability, the strap 110 can branch off near the attachment member 114, allowing for the use of multiple attachment points 112 and multiple attachment members 114.

  To provide a consistent experience for the user at various treatment pressures, the headgear 110 is preferably substantially completely inextensible. For example, the headgear 110 can be formed entirely of a non-elastomeric material, or can include at least one generally non-elastomeric component that extends entirely from one of the mounting members 114 to the other of the mounting members 114. it can. In some configurations, the headgear has limited or substantially no creep. In other words, the headgear 110 may remain substantially the same length over its useful life; the material preferably does not shrink or stretch to any significant degree. By way of example, and not limitation, a material that is entirely non-elastic and has limited or no creep is suede.

  Surprisingly, a totally non-elastic headgear assembly (eg, a headgear that allows for less than about 1 percent elastic elongation at a force of about 5 Newtons or less) provides more user comfort and sealing than elastic headgear. It has been found to improve performance. The generally non-elastic headgear 110 does not extend as the treatment pressure increases or changes over the course of the treatment. Rather, the headgear simply reacts to oppose any forces generated by the seal during use. As such, when adjusted for proper application at high therapeutic pressures, the user does not feel too cramped when the pressure drops to low therapeutic pressures. Furthermore, once the headgear is adjusted and ready for use, there is generally less or no preload experienced by the user before the onset of therapeutic pressure.

  For generally non-elastic headgear 110, headgear 110 preferably includes a method for adjusting the length of the loop defined by interface 100 (eg, headgear 110 and frame 104 of FIGS. 1 and 2). A number of ways to adjust is described below in greater detail: Adjustability facilitates customization of the user's installation of non-elastic headgear 110 on a particular physical anatomy.

  For a totally non-elastic headgear 110, the headgear 110 preferably includes a break-fit assembly. The break-fit assembly facilitates wearing of the interface 100, many of which are described below. The break-fit assembly facilitates a slight and controlled elongation of the loop defined by interface 100, allowing the loop to expand sufficiently to slide to a position around the user's head. The extra length allows the user to pull the interface over the maximum perimeter of the head while moving the headgear, for example, to positions below and behind the maximum occiput. In some embodiments, the break-fit assembly provides about 0-200 mm expansion. This may be in one place or divided across both sides of the relevant interface.

  The break-fit assembly also preferably returns to its original position or use length once the interface 100 is properly worn. In some configurations, the break-fit assembly automatically returns when the interface 100 is worn.

  Seal 102 and frame 104 generally define a mask of the configuration shown. When breathing gas is delivered through conduit 106 to the cavity defined in the mask, a lifting force is generated by the mask and the mask attempts to move away from the user's face.

  The headgear 110 opposes the lifting force. As described above, the break-fit assembly allows for the elongation of the loop defined by interface 100 (eg, by temporarily increasing the length of the strap). The break-fit assembly preferably extends only after a release force has been applied to the assembly. The release force is greater than the maximum lifting force (ie, the maximum lifting force generated by the highest force expected in the treatment). In some configurations, the release force is between about 3 Newtons and about 8 Newtons.

  As mentioned above, the headgear 110 may also have a way to adjust the length of the loop. In some configurations, the length adjustment requires an adjustment force that exceeds the release force. In such an arrangement, a greater force is required to adjust the length than is required to operate the break-fit assembly. As such, the adjustment force is greater than the release force, and the release force is greater than the maximum lifting force. The adjustment force is also greater than the maximum lifting force, which may be particularly relevant if a break-fit assembly is not used.

  Although the above generally relates to the assembly of FIGS. 1-2, the description of materials and relative forces preferably applies to any assembly provided with either or both a break-fit assembly and an adjustment configuration. Furthermore, any combination of the mask, break-fit assembly, and adjustment configuration described herein is possible, specifically contemplated, and within the scope of the disclosure and some features of the invention, It should be understood that they are in aspects and advantages.

  Referring to FIG. 3, another interface 120 is shown. Interface 120 also includes seal 122, frame 124, conduit 126, and headgear 130. While the interface 100 of FIGS. 1 and 2 is a nasal interface, the interface 120 of FIG. 3 is a full-face interface. Some features, aspects, and advantages of the present invention can be used with any type of interface including, but not limited to, nasal, oral, nasal, full face, and the like.

  The illustrated headgear 130 includes a break-fit assembly 132 and an adjustment mechanism 134. Although the break-fit assembly 132 is shown with reference to the lower strap, the break-fit assembly 132 can also be used with any and / or all straps as desired. Although both the break-fit assembly 132 and the adjustment mechanism 134 are shown incorporated into the interface, it is also possible to incorporate only one of the break-fit assembly 132 and the adjustment mechanism 134 into the interface. Further, any suitable break-fit assembly and / or any suitable adjustment mechanism can be used.

  The headgear 130 preferably has a generally non-elastic portion 136, a break-fit assembly 132 that facilitates wearing of the interface 120, and an adjustment mechanism 134 that allows for customization of the headgear 130 to individual users. including. In some configurations, headgear 130 includes Breathoprene with the addition of non-extensible components. For example, the material may be a three-layer laminate (ie, foam, UBL (continuous loop), and non-extensible layer). In some configurations, the non-stretchable layer may be the center layer of a laminate of five or more layers: the non-stretchable layer includes a foam and UBL on both sides as the center layer.

  Referring now to FIG. 4, the interface 130 is shown while being worn by a user. As shown, the break-fit assembly 132 may extend from a first length L1 to a second length L2 that is greater than the first length L1. By extending from L1 to L2, the size of the loop defined by headgear 130 and frame 124 can be increased. By increasing the size of the loop, the loop can be sized as desired for normal use, but can be extended to a second larger size for wearing, providing the ability to quickly return to the desired size for normal use. There is no loss.

  FIG. 5 shows headgear 140 showing break-fit assembly 142 at another portion of the headgear, as compared to the configuration shown in FIG. In FIG. 5, the break-fit assembly 142 is positioned behind the headgear 140, while in FIG. 4, the break-fit assembly 132 includes a generally non-elastic portion 136 (shown in FIG. 3) of the headgear 130 and the frame 124. Is positioned between Thus, the break-fit assembly can be positioned between the generally non-elastic portion of the headgear and the frame, for example, as in FIG. 3, or the non-elastic portion of the headgear can be positioned between the break-fit assembly and the frame. Can be positioned between In some configurations, the break-fit assembly can be incorporated into headgear (eg, FIGS. 3 and 5).

  Still referring to FIG. 5, headgear 140 includes a generally non-elastic portion 144. The coupling portion 146 (several different embodiments are described in detail below) can be positioned along a separate seam 150. The seam 150 can be temporarily joined by the joining portion 146. In other words, the seam 150 is defined by two edges (shown in dashed lines), which can be separated, but when in close proximity, the two edges are joined by a coupling portion 146. In some configurations, coupling portion 146 includes one or more magnets. For example, two magnets, or one magnet and one magnetizable component (eg, an iron component) can be used.

  Still referring to FIG. 5, the return component 152 can be incorporated into the headgear 140. In the illustrated example, the return component 152 may include an elastic material. The return component 152 may span a gap that may exist between the two flaps 154 present on each side of the seam 150. As such, as the gap is widened by pulling the headgear 140 (see dashed line) and separating the two flaps 154, the return component 152 extends to allow the headgear 140 to be worn. When the headgear 140 is released, the return component 152 can function to return the headgear 140 to a position where the flaps 154 can touch each other, and the coupling portion 146 can join the flap 154 along the seam 150.

  In the illustrated example configuration, the return component 152 includes an elastic layer. For example, the return component 152 may include one or more portions formed of Lycra, a rubber band, and an elastic knit. The elastic layer is preferably capable of stretching up to about 40 mm when subjected to a tension of about 5 N (values may be different for large masks, for example full face masks). In some arrangements, the return component 152 may include strips, cords, bands, etc., rather than being full-length.

  In the illustrated configuration example, coupling portion 146 includes two components positioned below headgear 140. Such a position is desirable because it is difficult to feel when sleeping while wearing headgear 140. Other positions are possible. Further, while only two components are shown, more than two components can be used. In some configurations, the entire length of the seam 150, a substantial portion of the entire length of the seam 150, or most of the entire length of the seam 150 can be formed of a magnetic material or the like, and the coupling portion 146 also assists in pulling the seam 150 back together. it can.

  In some configurations, the break-fit assembly can be incorporated into the frame and / or seal. For example, with reference to FIGS. 6-8, the interface 160 has a frame 162 that incorporates a break-fit assembly 164. Therefore, the break-fit assembly 164 shown in FIGS. 6-8 is incorporated into a mask (eg, a frame of the mask).

  With continued reference to FIG. 6, the break-fit assembly 164 may include one or more flaps 166. Flap 166 can rest on outer surface 170 of frame 162. As shown, flap 166 can be connected to frame 162 by hinge 172. The illustrated flap 166 can be connected to the frame 162 by one or more hinges; three hinges 172 are used in the illustrated interface 160. In some configurations, a biasing member, such as a spring, may be used to provide a biasing force that has a tendency to return the flap 166 to a closed or latched position, the position of which is described below. .

  Any suitable method of holding the flap 166 in place against the outer surface 170 of the frame 162 can be used. In the illustrated configuration example, a magnetic coupling 174 is used. For example, the illustrated magnetic coupling 174 includes at least one magnet and at least one corresponding component from a magnetic material; the illustrated configuration includes, for each flap 166, two magnets and a And two corresponding components. For the coupling 174 to function, each paired component includes at least one magnet and at least one component formed of a magnetic material (eg, a material that is attracted to the magnet).

  Referring to FIG. 7, headgear 176 is connected to flap 166 in any suitable manner. The length of the flap 166 between the hinge 172 and the point at which the headgear 176 joins the flap 166 defines the length that the loop can extend (e.g., add two times this length). Therefore, increasing the distance between the hinge and the connection point can increase the length available for the break-fit assembly 164 (as shown in FIG. 6). Further, while a single flap 166 is shown, flap 166 may include two or more leaves that can fold over each other like a bellows. Therefore, multiples of the length between the hinge and the point of connection can be obtained.

  Still referring to FIG. 7, the flaps 166 may open independently of one another. On the left side of FIG. 7, flap 166 is open and connected to headgear 176. On the right side of FIG. 7, the flap 166 is shown in solid lines in the closed or latched position and is shown to move to the open position. As indicated by the dashed arrow, the flap 166 moves between a latched position and an open position. 8, both flaps 166 are shown in a closed position, and on the right side of FIG. 8, both flaps 166 are shown in an open position. The movement is indicated by a broken line in FIG.

  Referring now to FIG. 9, the interface 180 has a frame 182 and headgear 184. A break-fit assembly 186 can be positioned between the frame 182 and the headgear 184. Headgear 184 may include a generally non-elastic portion 190. A generally non-elastic portion 190 may extend between the two break-fit assemblies. At least one break-fit assembly can directly (see FIG. 10) or indirectly (see FIG. 9) the generally non-elastic portion 190 to the frame 182. In the example configuration of FIG. 9, two break-fit assemblies connect the generally non-elastic portion 190 to the frame 182.

  Break-fit assembly 186 includes two magnetic members 192. As described above, the magnetic member 192 may include at least one magnet or a combination of at least one magnet and at least one magnetizable member (eg, a ferrous material). The magnetic members 192 are oriented to attract each other. As such, the magnetic member 192 is brought into a range where it can be magnetically coupled, and the magnetic member 192 is self-aligned and self-connected.

  The magnetic members 192 have a range of movement relative to each other, thereby moving the magnetic members 192 out of magnetic coupling. For example, when the magnetic member 192 moves away beyond about 10 to about 20 mm, the magnetic coupling force is not strong enough to retract the magnetic member 192 together.

  As a result, a flexible sheath 194 can encase the magnetic member 192 to assist in reconnection and alignment. Because the magnetic member 192 is very generous with respect to alignment, the flexible sheath 194 guides the magnetic member 192 back together and retains the magnetic member 192 in approximately the same path for reconnection. It is enough. Flexible sheath 194 may be any suitable elastic material. In some configurations, the flexible sheath 194 may be formed from silicone, an extensible plastic material, an extensible rubber material, or an extensible textile.

  Magnetic member 192 can be secured at least axially within flexible sheath 194. In some configurations, the magnetic member 192 can be rotatably and / or axially secured within the flexible sheath 194. Magnetic member 192 may be attached to flexible sheath 194 in any suitable manner. For example, without limitation, the magnetic member 192 can be glued, sewn, overmolded, etc., to secure the magnetic member 192 and the flexible sheath 194 together.

  The magnetic member 192 closest to the frame 182 can be attached to the frame 182 directly (see FIG. 10) or indirectly (see FIG. 9). The magnetic member furthest from the frame 182 can be attached to the end of a generally non-elastic member 190. In some configurations, as shown in FIG. 9, for example, but not limited to, the magnetic member 194 furthest from the frame 182 may be directly connected to the end of the generally non-elastic member 190 Can be.

  In the illustrated configuration, a portion of the sheath 194 extends along and / or wraps around at least a portion of the non-elastic member 190. In some configurations, the sheath 194 extends all or substantially all of the distance from one side of the frame 182 to the other side of the frame 182. Further, in some configurations, the sheath 194 can be secured to at least a portion of the non-elastic member 190. For example, the sheath 194 can be joined to at least a portion of the non-elastic member 190. Other configurations are possible. In the illustrated configuration example, the distance from the laterally outermost portion of the sheath 194 to the magnetic member 192 fixed to the non-elastic member 190 generally does not change. However, the distance from the laterally innermost portion of the sheath 194 to that same magnetic member 192 varies due to the stretching of the sheath 194.

As shown in FIG. 9, when the outer magnetic member 192 moves away from the inner magnetic member 192, the length of the headgear 180 increases. Movement of the magnetic members 192 away from each other is resisted by the elastic material of the sheath 194. Thus, stretching of the sheath 194 establishes a restoring force that acts to return the magnetic members 192 toward each other to a rest position for reconnection. The rest position is the position where the break-fit assembly is connected with enough force to withstand the force created by the interface seal during dragging the hose in addition to the normal use of the CPAP. The hose drag may be any force applied to the mask system by the CPAP hose pulling away from the user or dragging over any surface. In other words, the force coupling the magnetic member 192 preferably exceeds the maximum force generated by the pressurized breathing gas in the interface, which pressurized gas is generated by the force of the CPAP blower. . For example, but not by way of limitation, at about 20 cm H ₂ O, the magnetic member 192 preferably applies a binding force greater than about 5 N because there is about 5 N of force moving the mask away from the user's face. . In some configurations, the magnetic force is preferably greater than about 4-5 N, which is due to the relatively high therapeutic pressure (eg, about 20 cm H ₂ O) and sealing of the patient's geometry. Takes into account that it is difficult.

  Referring now to FIGS. 11-17, an additional break-fit assembly is shown. The break-fit assembly shown in FIGS. 11-17 achieves the break-fit function by using a mechanical coupling rather than a magnetic coupling. Each of the break-fit assemblies can be coupled to non-elastic headgear as described above, and can be used instead of or in addition to any of the other break-fit assemblies described herein. As described above, the break-fit assembly facilitates temporary expansion of the loop defined by the interface and simplifies wearing; in some configurations, the mechanical described herein. The arrangement can provide an extension of about 25 mm to about 100 mm. In some configuration examples, the extension is between about 30 mm and about 70 mm. In some configuration examples, the extension is about 50 mm. Note that mechanical break-fit assemblies tend to be longer in axial length than magnetic break-fit assemblies. However, mechanical break-fit assemblies have other distinct advantages over the use of magnets.

  Referring first to FIGS. 11 and 12, the break-fit assembly 200 has a structure that allows the first and second components to be separated by a predetermined force, while the first Facilitates mechanical rejoining of the second component to the second component. In the embodiments shown in FIGS. 11 and 12, the first component can include a post 202 with a head 204 and the second component can include a receptacle 206 with a resilient opening 210. Can be. The first component and the second component can be joined by a biasing member 212, such as, but not limited to, an elasticized sleeve or spring. The biasing member 212 can be secured to the first component and the second component in any suitable manner. Further, in the illustrated configuration example, the biasing member 212 overlies any gap that occurs when the first and second components are separated. Thus, biasing member 212 may serve to guide reconnection of the first component and the second component.

  The head 204 in the illustrated configuration has a gentle beveled portion 216 and a steeper angled portion 214. Similarly, receptacle 206 has a gently sloped portion 220 and a more acutely angled portion 222. However, surfaces 214, 216, 220, 222 are one configuration of surfaces that can be used. Conveniently, the illustrated configuration using the gently sloping interfaces 216, 220 promotes a low coupling force while producing a higher separation force by using the more acutely angled interfaces 214, 222. . As a result, the illustrated break-fit assembly 200 separates with a relatively higher force than that required by the assembly 200 to rejoin. As with the assemblies described above, preferably, the assembly 200 separates with a tensile load of about 4N or 5N or more.

  Referring now to FIGS. 13-15, another break-fit assembly 230 allows for the separation of the first and second components with a predetermined force while maintaining mechanical force. Has a structure that facilitates rejoining of the first component and the second component. In the illustrated embodiment of FIGS. 13-15, the first component can include a post 232 with a head 234, and the second component can include a receptacle 236 with an opening 240. it can. Post 232 may extend through a wall defining receptacle 236. As such, post 232 can slide within receptacle 236. As the post 232 slides within the receptacle 236, alignment generally occurs.

  The return force between the first component and the second component may be generated by the biasing member 242. In the illustrated assembly 230, the biasing member is positioned within the second component. As shown, the biasing member 242 is positioned within the receptacle 236. The biasing member 242 may be, for example, without limitation, a spring. The illustrated urging member 242 includes a compression spring. A retainer 244 fixes the biasing member 242 above the post 232. The retainer can be formed integrally with the post 232 or can be formed separately and secured thereto in any suitable manner. Therefore, the biasing member 242 is supported by the surface of the receptacle 236 and the retainer 244.

  Referring to FIG. 14, the head 234 of the illustrated configuration has a gentle beveled portion 246 and a steeper angled portion 248. Similarly, receptacle 236 has a gently sloped portion 252 and a sharper angled portion 250. However, surfaces 246, 248, 250, 252 are one configuration of surfaces that can be used. Conveniently, the illustrated configuration using the gently sloping interfaces 246, 252 facilitates rejoining with low bonding forces while using the more acutely angled interfaces 248, 250. , Resulting in separation occurring at higher separation forces. As a result, the illustrated break-fit assembly 230 separates with a relatively higher force than the assembly 230 rejoins. As with the assemblies described above, preferably, the assembly 230 separates with a tensile load of about 4N or 5N or more.

  Referring now to FIGS. 16 and 17, another break-fit assembly 260 likewise allows for the separation of the first and second components with a predetermined force. And a structure that facilitates mechanical rejoining of the first component and the second component. In the embodiment shown in FIGS. 16 and 17, the first component can include a post 262 with a head 264 and the second component can include a receptacle 266 with an opening 270. it can. Post 262 can extend through a wall defining receptacle 266. As such, post 262 can slide within receptacle 266. Posts 262 sliding within receptacles 266 generally provide alignment.

  A return force between the first component and the second component may be generated by the biasing member 272. In the illustrated assembly 270, the biasing member overlies at least a portion of each of the first and second components. The biasing member 272 may be, for example, without limitation, a spring or an elastic sleeve. The illustrated biasing member 272 may be an elastic fabric sleeve that entirely encloses the first component and the second component.

  Referring to FIG. 17, the head 264 of the illustrated configuration has a gentle beveled portion 274 and a steeper angled portion 276. Similarly, receptacle 266 has a gentle beveled portion 280 and a more acutely angled portion 282. In the illustrated configuration, the gentle slope portion 280 of the second component includes the displaced inner wall of the receptacle 266, and the sharper angled portion 282 forms the gentle slope portion 280. Including the edge of the wall. However, surfaces 274, 276, 280, 282 are one configuration of surfaces that can be used. Conveniently, the illustrated configuration using the gently sloped interfaces 274, 280 promotes a low coupling force while producing a higher separation force by using the more acutely angled interfaces 276, 282. . As a result, the illustrated break-fit assembly 260 separates with a relatively higher force than the assembly 260 rejoins. As with the assemblies described above, preferably, the assembly 260 separates with a tensile load of about 4N or 5N or more.

  As described above, when using totally non-elastic headgear, a user may desire some form of adjustment. In some cases, the adjustment occurs during the construction of the device and no further adjustment is made. In other cases, the user may want to adjust the headgear as desired. As a result, FIGS. 3, 7, 9-11, and 18-62 illustrate various adjustment mechanisms arranged and configured in accordance with certain features, aspects, and advantages of the present invention.

  Referring first to FIG. 3, as shown above, the illustrated interface 120 includes an adjustment mechanism 134. 7 shows a similar adjustment mechanism 168, and FIG. 10 shows a similar adjustment mechanism 198. As a result, the following description of adjustment mechanism 134 shown in FIG. 3 may equally apply to adjustment mechanism 168 shown in FIG. 7 and / or adjustment mechanism 198 shown in FIG.

  Adjustment mechanism 134 is a simple buckle 135 with a hook-and-loop fastener configuration 138 formed in a non-elastic portion 136 of headgear 130. The tabs of the hook-and-loop fastener arrangement 138 pass through the opening defined in the buckle 135 and are then returned in place, for example, but not limited to, being doubled on itself. Can be fixed. Other buckle configurations can be used, including pin-based buckles and the like.

  With continued reference to FIG. 3, headgear 130 may be connected to the rest of interface 120 using hooks 139 or the like. As shown, hook 139 may be connected to a mounting structure formed on or connected to at least one of frame 124 and seal 122. Other assemblies are possible. In the configuration example shown in FIG. 3, both the upper strap and the lower strap include the adjusting mechanism 134.

  Referring now to FIG. 9, another adjustment mechanism 187 is shown. Adjustment mechanism 187 may include an insert 188 that includes teeth 189 and is secured to break-fit assembly 186. Insert 188 can mate with an opening in frame 182. Insert 188 interlocks with the structure of frame 182. In some configurations, the teeth 189 of the insert 188 interlock with the structure of the frame 182. Preferably, the insert 188 is easy to move inward into the frame 182, but rather difficult to retract from the frame 182. Use the adjusting force to adjust the headgear. In some configurations, the frame 182 may include a release button that, when pressed, facilitates withdrawal of the insert 188 from the frame 182.

  Referring now to FIGS. 18-20, interface 290 includes frame 292 and seal 294. Headgear 296 is connected to frame 292 in any suitable manner. Headgear 296 includes a generally non-elastic member 300 and an outer cover member 302. Outer cover member 302 may include an elastic sleeve. Elastic sleeve 302 can be attached to frame 292 in any suitable manner. The generally non-elastic member 300 is substantially free to move within the sleeve 302.

  Referring to FIGS. 19 and 20, the generally non-elastic inner member 300 has a first end 304 and a second end 306. First end 304 and second end 306 may overlap in an area within frame 292. Movement of the ends 304, 306 changes the size of the loop defined by the headgear 296 and the frame 292 in the illustrated configuration. The extensible material of the elastic sleeve 302 proves to be a force that urges the generally non-elastic inner member to a first position (eg, the position shown in FIG. 19); however, the extensible material of the elastic sleeve 302 Allows the ends 304, 306 to slide relative to each other so that the loop can expand. Therefore, while wearing the interface 290, the headgear can expand and, when released, the elastic sleeve 302 attempts to return the headgear to its initial position.

  Referring again to FIG. 18, the frame 292 may include a lock button 310. Although a centrally located lock button 310 is shown, more than one lock button can be used. In some configurations, a separate lock button may be used for each of the ends 304, 306, and the lock buttons may be located lateral to the center point.

  In some configurations, pressing the lock button 310 releases the ends 304, 306 and allows one or both of the ends 304, 306 to move. In some configurations, pressing the lock button 310 allows the ends 304, 306 to be locked to each other and to the frame 292, and the size of the loop does not change anymore. If the lock button 310 needs to be pressed to lock the ends 304, 306, the headgear 296 can be allowed to function like an elastic headgear until the lock button 310 is pressed. In some configurations, the lock button 310 operates a release mechanism (eg, a closing toggle) that allows movement when pressed, and in some configurations, the lock button 310 is Operate a clamping mechanism (eg, a friction brake) that reduces or eliminates the possibility of movement when pressed. Any suitable locking mechanism can be used.

  In the illustrated configuration example, stoppers 312 and 314 are provided at the ends of the ends 304 and 306. Stops 312, 314 can be used to limit the amount of extension provided by headgear 296. For example, the stops 312, 314 can be configured such that the ends 304, 306 can pass through the frame 292, but the stopper cannot pass completely through the frame 292. In some configuration examples, the stoppers 312, 314 are configured not to enter the frame 292 at all. Other configurations are possible.

  21-23 show another interface 320 having a frame 322, a seal 324, and headgear 326. FIG. The frame 322 having the illustrated configuration includes the adjustment mechanism 330. 22 and 23 illustrate a variation of the adjustment mechanism 330, mostly slightly different with respect to the biasing member.

  Adjustment mechanism 330 can be connected to headgear 326 in any suitable manner. For example, headgear 326 can be formed in a non-elastic member and can include hooks, clasps, or other mechanical connection members. Further, in some configurations, a break-fit assembly, including but not limited to any of the break-fit assemblies described herein, may be placed between headgear 326 and adjustment mechanism 330.

  Adjustment mechanism 330 can be positioned within the housing of frame 322. Adjustment mechanism 330 can be positioned about an inlet coupled to a supply conduit (not shown). Such positioning makes efficient use of space and results in a symmetrical configuration. Referring to FIG. 22, the adjustment mechanism 330 is shown in a simplified diagram. The adjustment mechanism 330 may include a reel disk 332 and a coil spring 334 (see FIG. 23). In some configuration examples, the coil spring can be omitted. In some configurations, an elastic outer member (not shown) may be used, similar to that used in the configurations of FIGS. 18-20, instead of the coil spring 334, as in FIG.

  At least one extendable member 336 can be connected to the reel disk 332. 21 shows two extendable members 336, while FIGS. 22 and 23 show a single extendable member. When using a single extendable member 336, the member 336 is preferably folded over on itself at least at one point. The extendable member 336 can be, for example, without limitation, a cord, string, tape, or the like. The extendable member 336 is preferably entirely non-elastic and mounted such that it can be unwound from the reel disc 332 and retracted back there.

  The reel disk 332 can be mounted on a spool or mandrel (not shown), allowing the reel disk 332 to rotate about an axis. A locking mechanism 338 may be provided to secure a length of the extendable member 336 extending from the housing. The reel disc 322 may include or be connected to a member including a locking structure 340, such as a recess, a tooth, or the like. The locking pin 342 can be biased against the locking structure 340, such as, but not limited to, a spring 344. In some configurations, a locking assembly that uses a friction brake or the like can be used. Desirably, the locking assembly reduces or eliminates the possibility that the extendable member will be further pulled out. The extendable member 336 can be retracted into the housing following obtaining a setting in some configurations, and the extendable member 336 preferably cannot be further withdrawn from the housing when locked.

  Referring to FIGS. 24-29, an interface 350 including a frame 352, a seal 354, and headgear 356 is shown. Adjustment mechanism 360 may be provided to connect headgear 356 to the rest of interface 350. Adjustment mechanism 360 includes a hoisting mechanism similar to that just described above. For example, the adjustment mechanism 360 includes a thin band of material 362, such as a cord, tape, or the like, that wraps or unwinds around the spool 364, and the band of material 362 can wrap around the spool 364.

  Referring to FIG. 25, headgear 356 can be entirely non-elastic and can be joined to band 362 in any suitable manner. In the illustrated configuration example, the headgear 356 and the band 362 can be connected by a shuttle member 366. Conveniently, by using shuttle 366, band 362 may be continuously maintained within frame 352. By keeping the band 362 within the frame 352, the band 362 can be formed of a very thin material, but is protected from wear and abuse.

  The shuttle member is configured to move axially along at least a portion of the frame 352. Movement of shuttle 366 toward spool 364 (eg, to the left in FIG. 25) serves to remove slack in headgear 356 (ie, shorten the loop) while moving away from spool 364 (eg, FIG. 25). Movement of the shuttle 366 (to the right of the head) serves to increase the slack in the headgear 356 (ie, lengthen the loop). Any suitable locking mechanism can be used to secure the assembly in the desired location. For example, any of the following can be locked in place: spool 364, band 362, shuttle 366, or headgear 356. In some configurations, spool 364 includes a locking mechanism as described above. In some configurations, the shuttle 366 may have detent components that make a sound when moving from one position to the next, or the shuttle 366 may have a clamped position and a freely slidable position. (For example, the clamping position occurs when shuttle 366 is pushed into a position on the frame component to clamp to the frame component, and the freely slidable position is when the shuttle is (Which can occur when the element can be pulled out and slid along the frame components).

  In the illustrated configuration example, the shuttle member 366 is positioned in a slot 370 formed in the frame 352. Slot 370 can be positioned as desired. For example, the slot 370 can be on a surface of the frame 352 facing the user, facing outwardly from the user, facing upwards, or facing downwards. Tick marks adjacent to slot 370 may help a user specify a desired setting. In some configuration examples, slots can be omitted (for example, see FIG. 27). In some configurations, the frame 352 may include an opening rather than simply a slot (see, for example, FIG. 28).

  As also shown in FIGS. 26-29, shuttle member 366 may be captured or connected to frame 352 in any desired manner. For example, shuttle member 366 can include a recess for receiving a flange of frame 352. In some configurations, the frame 352 may include a recess for receiving the flange of the shuttle member 366. Desirably, shuttle member 366 is connected to frame 352 such that shuttle member 366 can translate along at least a portion of frame 352.

  Referring now to FIGS. 30 and 31, two different adjustment mechanisms 380 are schematically illustrated. The mechanism 380 can be positioned in the frame of the interface (eg, in a recess in the frame) or in a separate housing. In some configurations, the mechanism 380 can be positioned, for example, but not limited to, a housing located along a portion of the headgear. As mentioned above, spools have been used to remove slack or adjust the length of headgear. In any of the configurations described herein, the take-up mechanism 380 can be used to adjust the length of the headgear. The illustrated mechanism 380 includes a first set of pins 382 and a second set of pins 384. A first set of pins 382 is positioned on a first body 386, and a second set of pins 384 is positioned on a second body 388.

  By moving the first body 386 relative to the second body 388, the length of the extendable member 390 can be adjusted. 30 shows a single member 390, while FIG. 31 shows two members 390, each member being fixed to one of the bodies (eg, first body 386).

  FIG. 30 shows a linear motion, while FIG. 31 shows a rotary motion. Advantageously, very small relative movement between the first body 386 and the second body 388 can cause a large change in the length of the extendable member 390. Increasing the number of pins 382, 384 increases the effect on length. By reducing the number of pins 382, 384, the effect on length is reduced.

  Any suitable exercise can be used. In FIG. 31, the outer body 386 may be rotated while the inner body 388 may remain stationary, or the outer body 386 may remain stationary, while the inner body 388 rotates or both bodies 386 , 388 may rotate. The relative movement may occur in any suitable way. For example, linear motion can be controlled by levers, buttons, etc., that can be connected to one or both of the bodies 386, 388. Rotational movement can also be controlled by dials, levers, buttons, and the like.

  Referring now to FIGS. 32-34, another interface 400 including a frame 402, a seal 404, and headgear 406 is shown. An adjustment mechanism 410 may be provided. Referring to FIGS. 33 and 34, the adjusting mechanism 410 includes a rack and pinion assembly.

  A pinion 412 can be mounted between the two racks 414. Pinion 412 and rack 414 can be positioned within frame 402. The ends of the rack 414 can be connected to or incorporated into the headgear 406. In some configurations, the rack 414 connects to the headgear 406 outside of the frame 402. In some configurations, rack 414 connects to headgear 406 inside frame 402. The rack 414 is flexible enough to slightly wrap around the pinion 412, providing more purchase between the rack 414 and the pinion 412 to provide a generally symmetric headgear. The rack may be aligned with the attachment. In some configuration examples, a relief recess 415 may be provided to increase the flexibility of the rack 414.

  Referring again to FIG. 32, a ring or other input device 416 may be positioned on the surface of the frame 402. For example, without limitation, ring 416 can be positioned on the front side of frame 402 and can surround a connector through which breathing gas is supplied to interface 400. The rotation of the input device 416 causes the pinion 412 to rotate.

  Pinion 412 includes teeth 418, and rack 414 includes cooperating teeth 420. As the pinion 412 rotates, the teeth 418, 420 move the rack 414 axially. In this way, the loop can be adjusted using the rack 414. Any suitable locking mechanism may be used to lock the position of headgear 406, rack 414, pinion 412 and / or ring 416. For example, rotation of pinion 412 and / or ring 416 can be prevented using a pin or the like. In some configurations, one or more movements of the headgear 406, rack 414, pinion 412, and / or ring 416 may be blocked using a friction brake, clamping mechanism, cam break member, or the like. Further, although not shown, a break-fit assembly can also be used. For example, input devices have limits that are adjustable and limit the range of rotation. In some such configurations, a coil spring or other biasing member urges the input device toward a limit associated with smaller sized headgear. As such, the headgear expands, but then automatically retracts to a predetermined use size under the influence of the biasing member.

  Referring now to FIGS. 35-37, a further adjustment mechanism 420 is shown. The adjustment mechanism 420 includes an elastic sleeve 422 and a post 424. Resilient sleeve 422 may be formed from any suitable material. In some configurations, the elastic sleeve 422 may be formed from, for example, but not limited to, silicone. In some configurations, the elastic sleeve 422 may be formed from a woven material that may or may not be elastic. Post 424 may be formed from any suitable material. In some configurations, the posts 424 may be formed, for example and without limitation, from steel rolls.

  The elastic sleeve 422 includes a passage 426. Passageway 426 has an inside diameter or inner dimension, which may be smaller than the outer shape or corresponding outer dimension of post 424. The post can be easily inserted into the passage 426. Inserting post 424 into passage 426 causes elastic sleeve 422 to expand. The stretching of the sleeve 422 causes the material to be clamped tightly on the post 424. Simply trying to tension the two members further tightens the interface between the sleeve 422 and the post 424. See FIG. As shown in FIG. 37, to release the post 424 from the sleeve 422, the end of the sleeve 422 can be manipulated to withdraw the post 424 while effectively limiting necking of the sleeve 422. Thus, by causing axial compression of the sleeve, the end of the sleeve 422 can be moved axially away from the post 424. Therefore, the sleeve 422 and the post 424 can form a very effective adjustment mechanism.

  Referring to FIGS. 38 and 39, these figures illustrate two ways to incorporate the adjustment mechanism 420 into the interface 428. As shown herein, post 424 can be formed as part of a mask (FIG. 38) or as part of headgear (FIG. 39), and sleeve 422 can be formed as part of headgear (FIG. 38). Alternatively, it can be formed as a part of a mask (FIG. 39). For components formed on the mask side, the components can be incorporated into a frame or seal. In FIG. 38, post 424 is formed as part of frame 430, while in FIG. 39, sleeve 422 is formed as part of seal 432. In addition, a scale 424 or other section may be provided along a portion of the post 424 to indicate the length of the post 424 supplied to the sleeve 422, as shown in FIG. In some configurations, the sleeve 422 may also include a compartment, or may replace the compartment 434 of the post 424.

  Referring to FIGS. 40 and 41, two additional adjustment mechanisms 450 are shown. As shown, the adjustment mechanism includes a sleeve 452 and a post 454. As in the configuration described above, post 454 is received within passage 456 of sleeve 452. As shown in FIG. 40, passage 456 may include one or more tabs 458 that resist pulling post 454 out of passage 456. For example, tab 458 may be sloped away from opening 460 of sleeve 452, or tab 458 may have sufficient flexibility and length to provide a post 454 in passage 456. As tab is inserted, tab 458 flexes away from opening 460. Attempts to pull post 454 out of passage 456 are resisted by tab 458, but with sufficient force, pulling out of post 454 is not prevented by the tab. The distance between the tabs is less than the diameter or width of the post 454, and as the post is inserted, the tab catches the post and bends inward. The length of the tabs and their material allow them to catch and deform the posts, thus increasing interference with the posts and requiring more force to remove the posts from the sleeve.

  As in the embodiment described above, the adjustment mechanism 450 can be formed between the headgear and the mask. For example, the post 454 can be connected to or formed integrally with a portion of the mask, while the sleeve 452 is formed with or connected to the headgear (see FIG. 40). In some configurations, sleeve 452 may be incorporated into or joined to hook 462. As such, sleeves 452 and hooks 462 are used to connect the mask and headgear together, while also providing adjustability. See FIG.

  Referring now to FIGS. 42-44, an interface 470 is shown. Interface 470 includes frame 472, seal 474, and headgear 476. An adjustment mechanism 480 connects the headgear 476 to the rest of the interface 470. For example, as shown in FIG. 44, the frame 472 can include a housing 482 that includes an adjustment mechanism 480, which is shown in FIGS. 42 and 43. The adjustment mechanism connects to the headgear 476.

  FIG. 43 shows that the adjustment mechanism 480 includes a plurality of telescoping members 484. The telescoping members 484 are designed to nest with each other. As such, when reduced, telescoping member 484 defines a first length, and when extended, telescoping member 484 has a second length that is greater than the first length. Stipulate. This relationship is best illustrated by comparing the left side of FIG. 42 with the right side of FIG.

  A connecting cable 486 can be used to provide symmetrical movement of the telescoping member 484. For example, the first connection cable 486 can join the upper part of the first member 484 to the lower part of the third member 484 by making a loop on the upper side of the second member 484 (see the cable at the top in FIG. 42). ). Similarly, the second connecting cable 486 can join the lower part of the third member 484 to the upper part of the first member 484 by making a loop under the lower part of the second member 484 (FIG. 42). See cable below). As member 484 moves, one or more cables 486 maintain a balanced position, thereby causing the members to move synchronously.

  The outermost member 484 can define an end magnet or magnetizable material to which it can be connected, or can define an end cap 490 of the adjustment mechanism 480. On top of the third member 484, another magnet or magnetic material can be placed that defines a base 491 adjacent the end cap 490 at one location. End cap 490 and base 491 may both include a magnet, respectively, or one may include a magnet while the other includes a magnetizable material. End cap 490 and base 491 are held together by magnetic force. Adjacent to each other, the distance or length between the bottom of the base 491 and the top of the end cap 490 is defined as L3. When a force in excess of the magnetic force is applied in the opposite direction, one or more magnets are separated to define a distance or length of L4, where L4 is greater than L3.

  End cap 490 and base 491 together provide the same or similar break-fit function as described in FIGS. 9 and 10. When an axial force is applied to end cap 490, end cap 490 pulls base 491 apart, thereby reducing tension on headgear 476, which may be beneficial to facilitate removal or adjustment. Because of the magnetic force between the end cap 490 and the base 491, the two elements may have a tendency to be pulled back together when the force holding them apart is removed or diminished. Other elements of the headgear 476 may also pull the two elements back together. For example, the elastic members 492 (as described in detail below) may include an elastic material that, when separated, pulls the end cap 490 and the base 491 back toward each other.

  In some embodiments, end cap 490 is mounted on top of telescoping member 484. In FIG. 42, the end cap 490 is shown as attached to the top of the fourth telescoping member 484. As the fourth telescoping member 484 slides relative to the third telescoping member 484, the base 491 positioned at the upper end of the third telescoping member 484 is adapted to accommodate such movement. May be configured. For example, in some embodiments, the base 491 includes an annular shape, which allows the fourth telescoping member 484 to slide with respect to both the base 491 and the third telescoping member 484. Such movement involves the break-fit operation of end cap 490 and base 491. In some embodiments, the base 491 includes any number of shapes with internal openings to accommodate the fourth telescoping member 484. In some embodiments, the base 491 is positioned on one or more sides of the slot 496 of the third telescoping member 484. Therefore, movement of the fourth telescoping member 484 is not hindered, and the end cap 490 can still be held in place by magnetic force.

  The member 484, the connecting cable 486, the end magnet and the end cap 490 can be surrounded by a resilient member 492. Any suitable elastic member 492 can be used. In some configurations, the elastic member 492 is a strip of material. In other applications, elastic member 492 forms an envelope around member 484 and end cap 490. As best shown in FIG. 42, the illustrated elastic member 492 provides resistance to movement of the end cap 490 away from the centerline CL. More importantly, the resilient member applies a restoring force when the member 484 extends outward.

  Telescoping member 484 is nested and slidably connected, and may include one or more connecting cables 486, so that locking only one of members 484 locks the entire assembly in place. In other words, the connecting cables 486 operate in a balanced state, so that by stopping the movement of one member 484 relative to another member 484, all of the members 484 are stopped. More specifically, by controlling the movement at lock point 494, the entire adjustment mechanism can be controlled. For example, clamping the middle member 484 and the adjacent member 484 together reduces or eliminates the possibility of other members 484 moving.

  Member 484 can include a slot 496. Pins 498 may extend between adjacent members 484 in the slots, such that the members are joined together. As shown in FIG. 44, one of the pins 498 may extend through a slot 500 formed in the housing 482 to provide a lock point 494. Other locking configurations can be used. For example, the plurality of stops may include pins that fit into one of the holes defining the plurality of stops. Desirably, the locking configuration eliminates movement between at least one of the members 484 and the housing 482, or eliminates movement between at least two adjacent members 484.

  Referring now to FIGS. 45-50, and particularly to FIGS. 47 and 48, an interface 510 having a frame 512, a seal 514, headgear 516, and an adjustment mechanism 520 is shown. Adjustment mechanism 520 may include a scissor mechanism, as described. In some configurations, adjustment mechanism 520 can be connected to frame 512. In some configurations, adjustment mechanism 520 can be positioned within housing 522. In some configurations, the housing 522 can be connected to the frame 512. In some configurations, housing 522 forms a portion of frame 512. In some configurations, the headgear 516 is connected to the frame 512 by an adjustment mechanism 520 housed within the housing 522.

  Referring to FIG. 47, the adjustment mechanism 520 preferably includes a first base component 530 and a second base component 532. In some configuration examples, the first and second components 530, 532 may include rings. The first ring 530 and the second ring 532 may be positioned side by side with a single axis of rotation extending through the two rings 530,532. First ring 530 includes two lugs 534 that are approximately 180 degrees apart. The second ring 532 includes two lugs 536 that are also approximately 180 degrees apart.

  A pair of intersecting scissor arms 540 connect lugs 534, 536 on each side of rings 530,532. The scissor arm 540 can be connected at a pin joint 542. Further, the connection between scissor arm 540 and lugs 534, 536 may be a pin joint. A set of scissor arms 540 is shown on each side of the adjustment mechanism 520, but other numbers can be used.

  Termination 544 can be connected to scissor arm 540 by stub arm 546. The first end of the stub arm can be connected to the scissor arm 540 by a pin joint. Similarly, the second end of the stub arm can be connected to the terminal end 544 by a pin joint.

  When the termination 544 is moved relative to the first ring 530 and the second ring 532, the stub arm 546 and the scissor arm 540 are folded and unfolded, while the first ring 530 and the second ring 532 rotate. . For example, as shown in FIG. 45, when the end 544 is in the retracted position, the angle α between the line extending through the axis of rotation of the lugs 534 and the rings 530, 532 and the pin joint of the scissor arm 540 is It is larger than when the part 544 is in the extended position. Therefore, the angle α decreases as the distance between the central axis CA and the terminal portion 544 increases.

  Adjustment mechanism 520 includes a biasing member 548. In the illustrated configuration example, the biasing member 548 urges the end portion 544 toward the central axis CA. In some configurations, biasing member 548 may be one or more strips of elastomeric material or spring members. In some configurations, the biasing member 548 may be an overlying stretch fabric or other material. Any suitable biasing member can be used. In some configurations, biasing member 548 is also housing 522. The biasing member provides a restoring force that attempts to return the end 544 to the retracted position.

  With further reference to FIGS. 45 and 46, the locking mechanism 550 can be used to lock the adjustment mechanism 520 in a desired position. For example, in the illustrated configuration, rings 530, 532 may include one or more recesses 552 extending around rings 530, 532. The recess may be, for example, but not limited to, in the form of a tooth. If the pin 554 engages the recess 552 and movement is not desired, the likelihood of rotation of the rings 530, 532 may be reduced or eliminated. In some configurations, only one of the first and second rings 530, 532 is secured for movement.

  Of course, any other suitable locking mechanism can be used. FIG. 49 shows the cam assembly 560. The cam assembly 560 can use a cam attached to a lever. The first and second rings 530, 532 can be crushed together from both sides by a cam. As such, when the lever is moved to the locked position, at least one of the first and second rings 530, 532 cannot rotate. In some configurations, both the first and second rings 530, 532 cannot rotate. Another mechanism shown in FIG. 50 may include a threaded ring assembly 562 that features a locking ring that tightens against at least one of the first and second rings 530,532. The locking ring, when tightened, can secure at least one or both of the first and second rings 530, 532 against rotation.

  As noted above, the adjustment mechanisms described herein can be used with a break-fit assembly if desired. The integration of the adjustment mechanism and the break-fit assembly will be described with reference to FIG. The adjustment mechanism has been described above. Termination 544 and plate 572 may be releasably coupled together to incorporate break-fit assembly 570. In some configuration examples, termination 544 and plate 572 may be magnetically coupled. In some configurations, at least one of the termination 544 and the plate 572 is or includes a magnet. The magnetic coupling between the termination 544 and the plate 572 is strong enough to remain connected during treatment, but sufficient to separate the termination 544 and the plate 572 when the interface 510 is worn. Weak enough. Elastic member 548 continues to extend beyond the full range of adjustment by adjustment mechanism 520 (eg, an additional approximately 50 mm). Thus, when the adjustment mechanism 520 is locked in a position between the retracted position and the extended position, the elastic member 548 is free when the plate 572 is free from the terminal end 544 while wearing the interface 510. Continue to stretch.

  With reference to FIGS. 45-48, an adjustment mechanism 520 is described that features coordinated expansion on both sides due to the interconnect rings 530, 532, but the adjustment mechanism 580 may have independent movement of the two sides. For example, the adjustment mechanism 580 shown in FIGS. 51-53 allows the two sides to be adjusted independently of each other. As shown, adjustment mechanism 580 may include at least a first gear 582 and a second gear 584. The first gear 582 and the second gear 584 can be engaged such that rotation of one of the gears 582, 584 causes rotation of the other of the gears 582, 584.

  First lever arm 586 can extend away from first gear 582, and second lever arm 588 can extend away from second gear 584. First lever arm 586 and first gear 582 are coupled for rotation, and second lever arm 588 and second gear 584 are coupled for rotation.

  A pair of intersecting scissor arms 590 are connected to lever arms 586,588. Both scissor arms 590 can be connected to each other at a pin joint 592. Further, the connection between scissor arm 590 and lever arms 582, 584 may be pin joints. Although a set of scissor arms 590 is shown on each side of the adjustment mechanism 580, other numbers can be used.

  Termination 594 may be connected to scissor arm 590 by stub arm 596. A first end of the stub arm 596 can be connected to the scissor arm 590 by a pin joint. Similarly, the second end of the stub arm 596 can be connected to the termination 594 by a pin joint.

  When the end 594 is moved with respect to the gears 582, 584, the stub arm 596 and the scissor arm 590 fold and spread, while the gears 582, 584 rotate. As shown in FIG. 51, the termination 594 can move between a retracted position (solid line) and an extended position (dashed line).

  As shown in FIG. 52, the adjustment mechanism 580 may include an elastic cover 598 similar to the configuration described above. Cover 598 surrounds the mechanical assembly and applies force to return the mechanism to the retracted position. Any of the biasing structures described herein can be used. Further, the break-fit assembly described above can be incorporated in the same manner. Effectively, in contrast to the other scissor arm assemblies described above, the assembly of FIGS. 51-53 replaces two rings with four gears and separates movement on two sides.

  As described above, it is possible to provide an adjustment mechanism using a hook-and-loop fastener having a buckle or the like. Referring to FIGS. 54-58, several assemblies are shown that can be used in place of hook and loop fasteners. These assemblies characterize components that can be formed of silicone or another polymeric material. As a result, these features facilitate molding with either headgear or another component of the interface.

  Referring to FIG. 54, strap 610 is shown folded back on itself to be doubled. Slider 612 can be used to slide over at least a portion of strap 610. Strap 610 may include one or more rails 614. As shown in FIG. 55, the rail 614 may include a thin rib 616 with an enlarged cap 618. As each is pressed together against each, each rail 614 may flex. As shown, the enlarged cap 618 interlocks itself to join the strap. Slider 612 helps to interlock rail 614 to slide over the double folded portion of strap 610. As an adjustment mechanism, the strap 610 allows a significant length to be used and can be used, and because of the structure and interlock of the rails 614, the strap 610 does not tend to hang its free end . In other words, excess length is easily managed.

  Referring to FIG. 57, another strap 620 is shown. The strap 620 includes two rails 622. Each of the rails 622 includes a C-shaped cap 624 that rests on a thin rib 626. As shown, when the straps are pressed together, one of the two caps 624 compresses and fits inside the other of the two caps 624. Thus, when the strap is folded over itself and doubled and pressed together, the double folded portion of the strap 620 can lock itself in the vertical direction.

  FIG. 57 also shows a second strap 630. Strap 630 includes four rails 632. Two of the rails 632 each include a C-shaped cap 634 that rests on a thin rib 636. Two of the rails 632 each include a small head 638 that rests on a thin rib 640. When pressed together, the small head 638 can fit into the recess of the C-shaped cap 634. Thus, when the strap 630 is folded over itself and doubled and pressed together, the strap 630 can lock itself in the vertical direction.

  FIG. 58 shows another strap 650. The strap 650 can lock itself in the lateral direction. As shown, the strap 650 may include an end 652 with a stop 654. Further, end 652 includes a tab 656, which may be sized to fit slider member 658. The slider member 658 can advance along the axial direction of the strap 650.

  One side of the illustrated strap 650 includes a laterally extending rib 660. The ribs 660 are shaped so that the ribs 660 can be locked together when pressed. The other side of the illustrated strap 650 is substantially smooth.

  The slider member 658 has an opening large enough to accommodate the two thicknesses of the strap 650 so long as the strap 650 has interlocking ribs 660. As a result, both sides of the tab portion 656 are generally smooth, and the position of the tab portion 656 can be adjusted when the slider member 658 is positioned above the tab portion 656 (see the lower part of FIG. 58). Once positioned as desired, slider member 658 can slide away from stop 654. As the slider member 658 crosses the strap 650, the ribs 660 are pressed together and the strap locks itself laterally.

  Referring now to FIGS. 59-62, an interface 700 is shown. Interface 700 includes mask frame 702, seal 704, and headgear 706. Adjustment mechanism 710 connects headgear 706 to the rest of interface 700.

  In the illustrated configuration example, the frame 704 includes an arm 712 extending laterally outward. As shown, arm 712 may include a concave groove 714 extending along one or both of the top and bottom.

  Headgear 706 connects to slide 720. In the illustrated configuration example, the headgear 706 is pivotally connected to the slide 720. Other types of connections can be used. Slide 720 may include teeth 722 that fit into each of concave grooves 714 of arm 712. The slide 720 must define an inner dimension that is larger than the corresponding outer dimension of the arm 712 so that the slide 720 can be compressed toward the arm 712.

  Referring to FIG. 60, slide 720 is generally locked in place along arm 712 until it is compressed. For example, as shown in FIG. 60, by compressing slide 720 in the direction of the teeth (eg, vertically as shown), release slide 720 and allow slide 720 to translate along arm 712. I do. FIG. 62 shows that slide 720 can include teeth or friction generator 722 that contacts arm 712 until slide 720 is compressed. As slide 720 is compressed toward arm 712, wall 724 of slide 720 deflects away from arm 712, thereby lifting teeth or friction generator 722 away from arm 712, and along arm 712. The movement of the slide 720 is facilitated.

  As shown in FIG. 61, arm 712 may include markings or indicia to assist in determining the position of slide 720 along the length of arm 712.

  As described above, non-extensible headgear generally indicates that the headgear needs to be set to a customized size specific to each user. Preferably, the sizing is done once, and then remains unchanged during subsequent use. Using the break-fit assembly described herein, sizing can be temporarily adjusted to facilitate wearing of the interface, while allowing automatic reconnection of headgear to a predetermined size. make it easier. As described above, the break-fit assembly may be connected to one or more of the headgear straps or to another portion of the headgear (eg, along the seam behind the headgear) to connect to the mask (eg, to the frame). Or a seal).

  In some configurations, the component assembly may be provided to reduce the risk of unexpectedly adjusting the predetermined sizing of the headgear. For example, but not by way of limitation, the component assembly can be made to actuate only the adjustment mechanism by intentional interaction. In one configuration, a key can be used to lock or unlock the adjustment mechanism. By key, we shall have an expanded interpretation of the device establishing control of the mechanism. The key can be a traditional key or another item. For example, the key can be a magnet or a magnetic component that attracts another component to interact with the adjustment mechanism. As another example, the key may be a household item, such as a screwdriver, pin, or the like. In one configuration, once the size has been adjusted, the components can be removed to lock the adjustment mechanism against inadvertent or unnecessary resizing.

  In some configurations, electronics can be added to improve the functionality of the interface. For example, a strap or other component may have a built-in track that functions as an electronic tape means. Once the initial installation of the interface has been performed (eg, by a sleep technician), the initial sizing may be bookmarked in the electronic components of the interface. For each subsequent interface attachment or wear, the electronics may signal when the headgear is at an appropriate or predetermined size. For example, the user may extend the interface while wearing and then tighten until the electronics indicate that the predetermined length has been reached. Similarly, an actuator may be provided for automatically tightening the interface to a predetermined size. The actuator may be a small motor, solenoid, or the like. The actuator can be incorporated into, for example, but not limited to, a frame or headgear. In addition, using electronics, the operating characteristics of the CPAP device can be monitored so that adjustments can be made automatically to the headgear to compensate for leaks as soon as they occur or are about to occur. .

  While various embodiments have been described, it should be noted that any of the adjustment mechanisms may be combined with any of the break-fit assemblies. Further, the adjustment mechanism can be used without a break-fit assembly, and the break-fit assembly can be used without an adjustment mechanism. Further, any interface (ie, mask and headgear) can be used with either or both of the adjustment mechanisms and / or break-fit assemblies described herein.

  Although the present invention has been described in terms of several embodiments, other embodiments will be apparent to those skilled in the art and are within the scope of the invention. Therefore, various changes and modifications may be made without departing from the spirit and scope of the invention. For example, various components may be further repositioned as desired. In addition, not all features, aspects and advantages are required to practice the present invention. As a result, the scope of the invention is to be defined only by the following claims.

Claims (8)

An interface assembly for use in providing respiratory therapy, the interface assembly comprising:
A mask including a frame and a seal supported by the frame;
Headgear connected to the mask,
A break-fit assembly positioned at the rear of the headgear, the break-fit assembly selectively extending a loop defined by the mask and the headgear when exceeding a predetermined force; and It is configured to return the loop to the use length when the predetermined force is not exceeded ,
The break-fit assembly includes a coupling portion including two components that remain connected in use when the predetermined force is not exceeded, wherein the two components exceed the predetermined force. Separating the loop to selectively lengthen,
The interface assembly , wherein the predetermined force exceeds a maximum lifting force generated by the mask when the respiratory gas is supplied to a cavity defined in the mask during use . The interface assembly according to claim 1, wherein the headgear is substantially inextensible. The interface assembly according to claim 1, wherein the coupling portion includes one or more magnets. 4. The break-fit assembly according to any one of the preceding claims, wherein the break-fit assembly includes a return component that functions to return the loop to the use length when the predetermined force is no longer exceeded. Interface assembly. The interface assembly according to claim 4, wherein the return component comprises an elastic layer. Applying a force in excess of the predetermined force may result in the extension of the loop allowing a user to wear and position the interface assembly on the user's head and face. 6. The interface assembly according to claim 1, wherein the interface assembly is sufficient to allow the user to remove the interface assembly from the user's head and face. 7. The interface assembly according to any one of claims 1 to 6, wherein the break-fit assembly returns the loop to the use length after a user has properly worn the interface assembly. The interface assembly according to claim 7, wherein the break-fit assembly automatically returns the loop to the use length after a user has properly worn the interface assembly.

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